An Open-label, Single Dose Study to Determine the Metabolism and Elimination of [14C]E2609 in Healthy Male Subjects

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Metabolite profiling in plasma, urine, and feces will be performed by liquid chromatography with radiodetection (radio-high performance liquid chromatography [HPLC]) methods. A scintillation counter and/or AMS will be used to detect radioactivity. If needed, plasma and feces samples will be treated with cysteine and/or other reagents before radio-HPLC analyses.

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Ages Eligible for Study:

18 Years to 55 Years (Adult)

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria

Subjects must meet criteria to be included in this study, including but not limited to the following:

Healthy male 18 - 55 years, inclusive, at the time of informed consent

Body mass index (BMI) of 18 to 32 kg/m2 at Screening

Subjects must have had a successful vasectomy (confirmed azoospermia) or they and their female partners not be of childbearing potential or must be practicing highly effective contraception throughout the study period and for 30 days after study drug discontinuation. Sperm donation is not allowed during the study period and for 30 days after study drug discontinuation.

Provide written informed consent

Willing and able to comply with all aspects of the protocol

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from this study:

Have participated in a 14C-research study within the 6 months prior to Day -2. The total exposure from this and any previous study must be within the recommended levels considered safe.

Exposure to clinically significant radiation within 12 months prior to Day -2.

Any laboratory abnormalities considered clinically significant by the investigator, which may require further investigations or treatment

Clinically significant illness which required medical treatment within 8 weeks or a clinically significant infection within 4 weeks of dosing

Any history of gastrointestinal surgery (e.g., hepatectomy, nephrotomy, digestive organ resection) that may affect PK profiles of study drugs

Hypersensitivity to the study drugs or any of their excipients

Known to be human immunodeficiency virus (HIV) positive

Restrictions will apply on prior and concomitant medications, food and beverages